Accredited TGA Agent for Medicines in Australia
Quality Matters Safety Matters Pty Ltd acts as an accredited TGA agent for more than 100 different sponsors of medicines and medical devices in Australia.
We strive to ensure that:
- All sponsors are fully aware of their obligations
- All sponsors have the resources on hand to realise their obligations
- All products are fit for purpose and correctly included in the ARTG
- Any issues, concerns or problems are dealt with promptly and professionally
Complementary Medicines
We offer a comprehensive listing service as well as expert assistance in:
- New complementary medicines substances
- Registered complementary medicines
- Compliance matters and more
Our listing services include:
- Full literature reviews, as well as copies of the full literature set
- SOPs describing obligations of sponsors (recall, customer complaints, stability testing, annual product review, adverse events reporting etc.)
- Liaison with your manufacturer
- Drafting of labels
- Documented label checks
- Submission of the approved draft
Our clients have more than 300 different medicines included on the ARTG.
PIC/S Good Manufacturing Practice
Quality Matters Safety Matters Pty Ltd offers a range of services including:
- Due diligence auditing for contract manufacture
- Mentoring in establishing GMP systems
- Documentation, training, auditing and debilitated validation expertise
- Due diligence for investigational medicines
- Trouble shooting and more
We have more than 25 years of experience in a wide range of dose forms, with a special focus on small and medium operations.
Our clients include:
- API manufacturers
- Liquid dose form manufacturers
- Solid dose form manufacturers
- Fermentation and bio-processors
- Australian and International businesses
OTC and Prescription Medicines
We don’t offer assistance with prescription medicine registrations but can connect you obligation free with people who can assist you.